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Trial record 19 of 75 for:    "Collagen Disease" | "Triamcinolone"

Study to Characterize the PK and Local Extent and Duration of Exposure From FX006 in Patients With OA of the Knee

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ClinicalTrials.gov Identifier: NCT02637323
Recruitment Status : Completed
First Posted : December 22, 2015
Results First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Flexion Therapeutics, Inc.

Brief Summary:
The objectives of this study were to characterize the local extent and duration of exposure of TA from FX006 and TCA IR, characterize the systemic PK of FX006 and TCA IR, and assess the safety and general tolerability of a single 5 mL IA injection of 32 mg FX006 relative to 40 mg of TCA IR in patients with OA of the knee.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Drug: FX006 32 mg Drug: TCA IR 40 Phase 2

Detailed Description:

This study employed an open-label, single administration design and was conducted in male and female patients ≥40 years of age with OA of the knee.

Patients were enrolled sequentially with at least 10 patients per cohort as follows:

Cohort A: FX006 32 mg, Final Visit at Week 20 Cohort B: FX006 32 mg, Final Visit at Week 16 Cohort C: FX006 32 mg, Final Visit at Week 12 Cohort D: FX006 32 mg, Final Visit at Week 6 Cohort E: FX006 32 mg, Final Visit at Week 1 Cohort F: TCA IR 40 mg, Final Visit Week 6

Each patient was screened to confirm eligibility and assigned to a cohort on Day 1/baseline. Each patient was evaluated for safety during his/her participation in the study at 6, 12, 16, or 20 weeks following a single IA injection depending on the assigned Cohort, and plasma and synovial fluid was collected for drug concentration measurements.

Safety and tolerability was assessed by physical examinations, index knee examinations, vital signs, clinical laboratory evaluations, and adverse events (AEs).

No efficacy assessments were employed in this study.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single Administration Study to Characterize the Systemic Pharmacokinetics and Local Extent and Duration of Exposure of Triamcinolone Acetonide From FX006 in Patients With Osteoarthritis of the Knee
Study Start Date : November 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016


Arm Intervention/treatment
Experimental: FX006 32 mg
Single 5 mL intra-articular (IA) injection Extended-release formulation
Drug: FX006 32 mg
Single 5 mL IA injection
Other Name: Zilretta

Active Comparator: TCA IR 40 mg
Commercially available triamcinolone acetonide, single 1 mL intra-articular (IA) injection Immediate-release formulation
Drug: TCA IR 40
Single 1 mL IA injection
Other Names:
  • Kenalog®-40 Injection
  • Triamcinolone Acetonide Crystalline Suspension (TAcs)




Primary Outcome Measures :
  1. Synovial Fluid Drug Concentrations (pg/mL) by Time Point Pooled Across FX006 Cohorts and TCA IR in Synovial Fluid [ Time Frame: Up to 20 Weeks ]
    All baseline (pre-treatment) values and all post-baseline values recorded as below LLOQ (<50 pg/mL) were set to zero. Geometric mean summary statistics were computed on adjusted concentration values. One (1) was added to each concentration value observed. BLQ values for the computation of geometric mean are included in the summary with a value of 1 (0+1).


Secondary Outcome Measures :
  1. Plasma Drug Concentrations (pg/mL) by Time Pooled Across FX006 Cohorts and TCA IR 40 mg Cohort [ Time Frame: Up to 20 Weeks ]
    All baseline (pre-treatment) values and all post-baseline values that are recorded as below LLOQ were set to zero for analysis and were included in the descriptive mean calculations. Values below LLOQ were not included in geometric mean calculations.


Other Outcome Measures:
  1. Plasma Pharmacokinetic Parameters for FX006 and TCA IR [ Time Frame: Up to 20 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written consent to participate in the study
  • Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
  • Symptoms associated with OA of the knee for ≥ 6 months prior to Screening (patient reported is acceptable)
  • Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
  • Index knee pain for >15 days over the last month (as reported by the patient)
  • Body mass index (BMI) ≤ 40 kg/m2
  • Ambulatory and in good general health

Exclusion Criteria:

  • Fibromyalgia, Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
  • History of infection in the index knee joint
  • Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
  • Presence of surgical hardware or other foreign body in the index knee
  • Unstable joint within 12 months of Screening
  • IA corticosteroid (investigational or marketed) in any joint within 6 months of Screening
  • IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
  • Intravenous or Intramuscular corticosteroids (investigational or marketed) within 3 months of Screening
  • Oral corticosteroids (investigational or marketed) within 1 month of Screening
  • Inhaled, intranasal or topical corticosteroids (investigational or marketed) within 2 weeks of Screening
  • Any other IA investigational drug/biologic use within 6 months of Screening or 5 half-lives (whichever is longer)
  • Prior use of FX006
  • Women of child-bearing potential not using effective contraception or who are pregnant or nursing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02637323


Locations
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United States, California
Canoga Park, California, United States, 91303
San Diego, California, United States, 92103
United States, Florida
Hialeah, Florida, United States, 33012
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
Sponsors and Collaborators
Flexion Therapeutics, Inc.
Investigators
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Study Director: Neil Bodick, MD Flexion Therapeutics

Additional Information:
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Responsible Party: Flexion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02637323     History of Changes
Other Study ID Numbers: FX006-2015-009
First Posted: December 22, 2015    Key Record Dates
Results First Posted: January 12, 2018
Last Update Posted: January 12, 2018
Last Verified: December 2017

Keywords provided by Flexion Therapeutics, Inc.:
osteoarthritis
knee
pain
corticosteroid
intra-articular
injection

Additional relevant MeSH terms:
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Rheumatic Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action